Introduction
Patenting biopharmaceuticals in the Philippines involves a complex set of rules and guidelines that must be navigated carefully to ensure the protection of intellectual property. Here are the key insights into patentability, enforceability, and the scope of claims for biopharmaceutical patents in the Philippines.
Patentability Requirements
Novelty, Inventive Step, and Industrial Applicability
For a biopharmaceutical invention to be patentable in the Philippines, it must meet the standard substantive requirements of novelty, inventive step, and industrial applicability. These requirements are fundamental and apply to all fields of technology without discrimination[2].
Doctrine of Inherency
The Philippines Intellectual Property Code, supplemented by the QUAMA Guide, applies the Doctrine of Inherency to assess patentable subject matter and inventive step. This doctrine considers whether the claimed subject matter is a natural result that necessarily and inevitably flows from an explicit disclosure of the prior art. If it is, it will be deemed inherent and not patent eligible[1].
New Forms of Known Substances
A new form of a known substance must be non-inherent and show an enhancement in efficacy that is also non-inherent. Enhanced efficacy alone is not sufficient; it must be unexpected. This could include improvements in therapeutic efficacy, bioavailability, stability, or solubility. However, improved thermodynamic stability and lower hygroscopicity are generally considered inherent and do not contribute to patent eligibility[1].
New Use of Known Substances
Medical use claims for a known compound are considered inherent and unpatentable if they rely solely on features such as a new mode of administration, dosage regime, patient group, mechanism or technical effect, advantage to a known use, or clinical situation for a known treatment[1].
Enforceability of Patents
First-to-File System
The Philippines operates on a first-to-file system, where the company that first applies for patent rights has the best chance of having those rights registered, provided they are not successfully contested. Registration is necessary to enforce rights, with the exception of copyrights and well-known marks[2].
Opposition and Observations
While there is no formal pre-grant opposition procedure, third parties can make observations regarding the patent application within six months of its publication or the request for substantive examination. These observations are communicated to the applicant and considered during the examination process[5].
Scope of Claims
Allowable Claim Formats
Composition of matter claims, such as claims to compounds, compositions, and formulations, are generally patentable in the Philippines. However, claims to methods of medical treatment and medical use may face more complexities and must be carefully crafted to meet the patentability requirements[3].
Divisional Applications
Voluntary divisional applications must be filed within four months of the parent application being withdrawn or granted. Divisional applications can also be filed in response to a lack of unity objection, provided they are filed within four months after the examiner issues a final objection[5].
Examination and Prosecution Process
Filing and Publication
A patent application in the Philippines must satisfy formal requirements to be granted a filing date. The applicant has two months to remedy any deficiencies. Convention applications are published after 18 months from the priority date, along with the results of a prior art search and the application’s patent classification[5].
Substantive Examination
The applicant must file a request for substantive examination and pay the substantive examination fee within six months from the date of publication of the application for Convention applications, or at the date of entry into the national phase for PCT national phase entries[5].
Specific Considerations for Biopharmaceuticals
Micro-organisms
The Philippines is a signatory to the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure. The deposit must be made before filing the application, and the necessary information must be submitted within two months from a request by the examiner[5].
Utility Patents
While utility models or petty patents are available for inventions that are novel and industrially applicable, they have a shorter term of protection of seven years and cannot be extended. This is less relevant for biopharmaceuticals, which typically require the stronger protection offered by utility patents[5].
Data Exclusivity and Patent Term Extensions
No Data Exclusivity Protection
The Philippines does not offer data exclusivity protection, which means that generic manufacturers can use the data submitted by the original applicant to obtain regulatory approval for their own products without waiting for the original patent to expire[5].
No Patent Term Extensions
Unlike some other jurisdictions, the Philippines does not provide patent term extensions for biopharmaceutical patents. This means that the standard 20-year term from the date of filing applies, without any possibility of extension[5].
Key Takeaways
- Patentability Requirements: Biopharmaceutical inventions must meet the requirements of novelty, inventive step, and industrial applicability.
- Doctrine of Inherency: The Philippines applies the Doctrine of Inherency to assess whether the claimed subject matter is inherent and thus not patent eligible.
- Scope of Claims: Composition of matter claims are generally allowable, but method of treatment claims face more scrutiny.
- Examination and Prosecution: Careful management of the filing, publication, and substantive examination process is crucial.
- Specific Considerations: Micro-organism deposits and the absence of data exclusivity and patent term extensions are important factors.
FAQs
What are the key patentability requirements for biopharmaceuticals in the Philippines?
Biopharmaceutical inventions must be novel, involve an inventive step, and have industrial applicability. The Doctrine of Inherency is also applied to ensure that the claimed subject matter is not a mere discovery.
How does the Doctrine of Inherency affect patentability in the Philippines?
The Doctrine of Inherency considers whether the claimed subject matter is a natural result that necessarily and inevitably flows from an explicit disclosure of the prior art. If it is, it will be deemed inherent and not patent eligible.
Can method of treatment claims be patented in the Philippines?
Method of treatment claims face more complexities and are generally not patentable if they rely solely on features such as a new mode of administration or patient group.
Is data exclusivity protection available for biopharmaceuticals in the Philippines?
No, the Philippines does not offer data exclusivity protection, allowing generic manufacturers to use the data submitted by the original applicant.
Can patent terms be extended for biopharmaceutical patents in the Philippines?
No, the Philippines does not provide patent term extensions for biopharmaceutical patents, adhering to the standard 20-year term from the date of filing.
Sources
- Spruson & Ferguson, "Patentability of known pharmaceutical substances in the Philippines," November 11, 2021.
- Global Patent Filing, "Patentability of Pharmaceutical Substances in Philippines," December 1, 2022.
- Legalwise Seminars, "Patenting Pharmaceuticals in Southeast Asia - Legalwise Seminars," August 11, 2021.
- Indian Patent Office, "Manual for Patent Office Practice and Procedure," November 26, 2019.
- FPA Patent Attorneys, "The Philippines," accessed December 17, 2024.
